FDA pressed on ‘women’s Viagra’

Barbara Gattuso, 66, shown with husband Gregg Gattuso 67, took part in clinical trials for a drug aimed at restoring female libido and found it greatly improved her sexual desire.

Photo: Katherine Taylor /New York Times

Is sexual desire a human right? And are women entitled to a little pink pill to help them feel it?

Those questions are being raised in a campaign that is pressing the Food and Drug Administration to approve a pill aimed at restoring lost libido in women. The campaign, backed by the drug’s developer and some women’s groups, accuses the FDA of gender bias for approving Viagra and 25 other drugs to help men have sex, but none for women.

“Women have waited long enough,” the effort, known as Even the Score, says in an online petition that has gathered more than 40,000 signatures. “In 2015, gender equality should be the standard when it comes to access to treatments for sexual dysfunction.”

The drug, flibanserin, has been rejected twice by the FDA on the grounds that its very modest effectiveness was outweighed by side effects including sleepiness, dizziness and nausea. The first rejection, in 2010, followed a decision by a committee of outside advisers to the agency who unanimously opposed approval.

On Thursday, FDA advisers once again will consider whether flibanserin should be approved.

Sprout Pharmaceuticals, which now owns the drug, has submitted new data, including a study to demonstrate that the pill does not impair driving. Still, approval might hinge on whether the FDA agrees to interpret the old data in a new way and whether the politics of such drugs has changed.

Even the Score is backed by, among others, the National Council of Women’s Organizations, the Black Women’s Health Imperative, Jewish Women International and some medical groups including the Association of Reproductive Health Professionals. It has persuaded some members of Congress to write to the FDA and also has created a wicked spoof of a Viagra commercial.

A spokeswoman for the FDA said the agency “strongly rejects claims of gender bias.” She said that in 2012, the agency identified female sexual dysfunction as a priority and held a two-day public workshop on drug development for the condition in October.

“I was the one initiating sex, much to the surprise of my husband,” Barbara Gattuso of San Diego said at the workshop. Gattuso, who said she had had low desire for 25 years, said she was “devastated” when the trial ended.

But the path to a drug for women’s sexual dysfunction has been difficult. Pfizer gave up testing Viagra for women in 2004, the same year an FDA advisory committee voted against a testosterone skin patch for women developed by Procter & Gamble. A testosterone gel for women being developed by BioSante failed in clinical trials in 2011.

Some other women’s groups, including the National Women’s Health Network and Our Bodies Ourselves, say Even the Score is making a mockery of the drug approval process under the guise of women’s rights.

“I don’t think there is anything sexist about denying approval for drugs that don’t have an adequate risk-to-benefit ratio,” said Thea Cacchioni, an assistant professor of women’s studies at the University of Victoria in British Columbia, who is writing a book about the issue called “Big Pharma, Women, and the Labor of Love.”

Leonore Tiefer, a psychologist at the New York University School of Medicine, said Sprout and its allies were trying to make low desire into a medical problem treatable by drugs when “most of these problems are psychological or relational.”

Lack of spontaneous desire, she said, is not necessarily a problem in itself. The American Psychiatric Association no longer lists hypoactive sexual desire disorder, the condition flibanserin is designed to treat, in its manual of mental health disorders. Low desire now is combined with low arousal in a broader diagnosis on the grounds that some women do not feel desire until they are aroused.

Even the Score does exaggerate somewhat. Most of the 26 drugs for men are different formulations of the same substance, testosterone. And none are approved to treat low sexual desire, though that can be one symptom of testosterone deficiency. Viagra improves blood flow to the penis needed for an erection. For women, estrogens and a drug called ospemifene have been approved to treat pain during intercourse that can occur after menopause.

Still, even many members of the FDA advisory committee that rejected flibanserin in 2010 acknowledged then that lack of desire was a genuine condition and that drugs should be developed for it.

“Our usual patient is someone who is fearful of losing the relationship they have been in for years,” said Dr. Irwin Goldstein, director of sexual medicine at Alvarado Hospital in San Diego and a consultant to many drug companies. “It’s tragedy after tragedy after tragedy.”

One of his patients, Jodi Cole, 33, of Porter, Oklahoma, said her lack of desire “tends to cloud my thoughts of everything related to my husband.” She said that “replacing the dread I have for intimacy with desire would be life-changing.”

About 10 percent of U.S. women suffer from a lack of desire that causes distress, according to a survey conducted by an academic researcher but financed by Boehringer Ingelheim, the original developer of flibanserin. The drug, taken daily, would be for premenopausal women whose loss of desire was not from known causes such as disease or the side effect of a drug.

Goldstein said it was gender bias to categorize male sexual dysfunction as a simple physical problem and women’s as complex, psychological and unamenable to drugs. He noted that antidepressants that increase the level of serotonin in the brain can have a side effect of decreasing libido. Flibanserin does the opposite — transiently decreasing serotonin while raising levels of two other neurotransmitters, dopamine and norepinephrine.

Susan Scanlan, chairwoman of Even the Score, said the side effects of flibanserin, such as sleepiness and dizziness, were not so serious. By contrast, she said, Viagra and some other drugs for men can cause blindness, penile rupture and other serious side effects.

“The implication is that men can be trusted to make a rational decision of risk versus reward and women can’t,” she said.